Tolerance and Efficacy of Wondersun Infant Formula in Formula-fed Chinese Term Infants
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|ClinicalTrials.gov Identifier: NCT01157390|
Recruitment Status : Completed
First Posted : July 7, 2010
Last Update Posted : June 8, 2017
Objective: To demonstrate the well-being of Chinese term infants fed with Wondersun formula with high proportion of palmitic acid in the sn-2 position.
Design & setting: A single-center, open label study. A breast fed group will serve as reference. The study will be conducted in Guangzhou from 2010.1~2010.12.
Participants: 0-14 d whole formula-fed infants and whole breast-fed infants, 30 infants in each group. They are required to be healthy, term-infant, and with normal birth weight, and have no medications known to affect their growth and development.
Intervention: The formula-fed infants will be fed Wondersun formula with high proportion of palmitic acid in the sn-2 position; and breast-fed groups will be fed using breast milk for at least 3 month.
Outcome measures: Tolerance and efficacy will be assessed by body measurement, stool characteristics questionnaire, general health examination, and behavior and habit questionnaire at baseline (0-14d), 6 weeks and 12 weeks. Safety will also be evaluated.
Statistical analysis: t-test, rank test and chi-square test will be used to examine the significance of change from baseline to follow-up visit between the formula-fed and breast-fed groups for effectiveness measures
|Condition or disease||Intervention/treatment||Phase|
|Infant Nutrition||Other: Infant formula Other: Breast feeding||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Tolerance and Efficacy of Wondersun Infant Formula in Formula-fed Chinese Term Infants: an Open Label, Controlled Trial|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||June 2011|
Experimental: Infant formula
The infants will be fed with Wondersun infant formula with high proportion of palmitic acid at the sn-2 position
Other: Infant formula
Name: Infant formula with high proportion of palmitic acid in the sn-2 position Dosage & frequency: Fed as need Duration: at least 3 months
Other Name: Wondersun Brand An Li Cong Infant Formula
Active Comparator: Breast feeding
Complete breast feed within the first 3 month
Other: Breast feeding
Other Name: Not relevant
- Anthropometric parameters [ Time Frame: 12 weeks ]body length, body weight, and head circumferences
- Efficacy and safety [ Time Frame: 6 weeks ]Stool characteristics General health and wellbeing Behavior and habits Adverse events Concomitant medications Covariates or potential confounders
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01157390
|The Third Affiliated Hospital of Sun Yat-sen University|
|Guangzhou, Guangdong, China, 510630|
|Principal Investigator:||Yuming Chen, PhD||Sun Yat-sen University|